Author: Lori
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FDA LDT Final Rule
The LDT final rule intends to improve patient safety by ensuring LDTs meet the same standards as other medical devices. The rule also provides wider exemptions than previously anticipated for LDTs already on the market. It includes a phased, five-stage “phase-out” of enforcement discretion over four years, demanding escalating compliance from labs, with certain exemptions for tests…
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ISO 13485 Explained
ISO 13485 is the internationally recognized quality management benchmark for medical device manufacturers. The ‘ISO’ in ISO 13485 stands for the International Organization for Standardization, which publishes the international standards governing most modern industries. Getting ISO 13485 certified guarantees the trust of regulators, stakeholders, and future customers while quickening route to market with ISO1345 compliance. ISO 13485 is an…
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CDRH and CBER Breakthrough Device Marketing Authorizations List
CDRH leads the way with the most products approved as this list notes of Breakthrough Device Marketing Authorizations. These guidances are related to the Breakthrough Devices Program: Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program Final Guidance: Breakthrough Devices Program Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket…
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FDA List of Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices
FDA posts a list of Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices. It is so helpful in understanding the agency’s evaluation of appropriate study diversity based on the device’s intended use and technological characteristics.
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Design Control for Medical Device Manufacturers
The FDA Center for Devices and Radiological Health (CDRH) March 11, 1997 issued the Guidance “Design Control Guidance for Medical Device Manufacturers“. This guidance is key to understand and implement today.
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International Medical Device Regulators Forum (IMDF)
The purpose of the International Medical Device Regulators Forum (IMDF) is to develop global regulatory device best practices. IMDF working groups post a technical document called “Non-In Vitro Diagnostic Device Regulatory Submission Table of Contents (nIVD ToC).” This useful global template compares common elements and denotes regional differences. When submitting 510(k) and PMAs to the…
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Does My Study Require An IDE?
To launch a US medical device study, an approved Investigational Device Exemption (IDE) may be required. 21CFR 812 is part of the Code of Federal Regulations (CFR) containing the procedures and requirements governing the conduct of clinical research of devices. If needed, FDA clearly describes the IDE application format. According to the regulations of 21 CFR 812,…
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Nitrosamine Impurities
On August 4, 2023, the U.S. Food and Drug Administration (FDA or Agency) issued a final guidance for immediate implementation entitled Recommended Acceptable Intake Limits for Nitrosamine Drug Substance-Related Impurities (NDSRIs) (Guidance). NDSRIs are a subcategory of nitrosamine impurities that share structural similarity to the active pharmaceutical ingredient (API) in drug products and typically lack compound-specific…